N/A
N=30
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
Prostatectomy
Bottom Line
View on ClinicalTrials.gov: NCT03624465 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Tools Required to Retract the Prostate During Procedure — 0 Additional Tools to Mobilize Liver
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levita Magnetic Surgical System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Levita Magnetics
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Tools Required to Retract the Prostate During Procedure |
— | — |
| PRIMARY Incidence of Device Related Adverse Events (Safety) |
— | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective prostatectomy surgery
Exclusion Criteria
- Significant comorbidities
- Subjects with pacemakers, defibrillators, or other electromedical implants
- Subjects with ferromagnetic implants
- Clinical history of impaired coagulation
- Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
- Subject is not likely to comply with the follow-up evaluation schedule
- Subject is participating in another clinical trial
Data sourced from ClinicalTrials.gov (NCT03624465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.